It Just Got Easier for Physicians to Help Their Patients Gain Access to Investigational Treatments | FDA

It Just Got Easier for Physicians to Help Their Patients Gain Access to Investigational Treatments | FDA

New Resource Lets Physicians Request Certain Types of Expanded Access Electronically

The Reagan-Udall Foundation, with input from the U.S. Food and Drug Administration, has launched Expanded Access (EA) eRequest. This tool makes it easier for physicians to request certain types of expanded access treatments for their patients.  Expanded access is a pathway for patients with a serious or life-threatening disease or condition, and no comparable or satisfactory alternative therapy, to obtain an unapproved investigational drug or biologic provided the manufacturer will offer the drug for this use. EA eRequest will accept applications for individual patient expanded access for drugs and biologics in non-emergency settings. EA eRequest assists physicians in determining if expanded access is appropriate for a particular patient. If so, the web platform helps physicians complete the Form FDA 3926 — which is used to request individual patient expanded access use — and submit it to the agency for approval. Physicians can upload other relevant documents for FDA review through the platform as well. EA eRequest is intuitive and more streamlined than the current mechanism for applying for individual patient expanded access in non-emergency settings. For example, EA eRequest auto-populates forms with information entered during registration; lets physicians upload relevant documents; provides checklists, links and other resources; and securely submits applications to FDA. The platform has other useful links and resources, such as information about emergency expanded access, expanded access for devices, and information on clinical trials. There are also resources for patients and caregivers.